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This study will look at the pharmacokinetics, safety, toleration and efficacy of PF-00610355 in the chronic obstructive pulmonary disease (COPD) population. The doses in this study are intended to explore the anticipated clinical dose range.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF- 00610355 | Experimental |
| |
| PF-00610355 | Experimental |
| |
| PF -00610355 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-00610355 | Drug | dry powder inhaler, 1472 mcg, single dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To characterize the single dose pharmacokinetics of inhaled PF-00610355 in COPD patients. | up to 8 days post dose | |
| To evaluate the safety & toleration of single inhaled doses of PF-00610355 in COPD patients | up to 24 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| To investigate the efficacy of a single inhaled dose of PF-00610355 in COPD patients. | up to 24 hours post dose | |
| To investigate the exposure/response relationship of PF-00610355. | up to 8 days post dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Berlin | 10117 | Germany | |||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| C552705 | N-((4'-hydroxybiphenyl-3-yl)methyl)-2-(3-(2-((-2-hydroxy-2-(4-hydroxy-3-((methylsulfonyl)amino)phenyl)ethyl)amino)-2-methylpropyl)phenyl)acetamide |
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| PF-00610355 |
| Drug |
dry powder inhaler, 736 mcg, single dose |
|
| PF-00610355 | Drug | dry powder inhaler, 368 mcg, single dose |
|
| Placebo | Drug | Placebo |
|
| Wiesbaden |
| 65187 |
| Germany |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |